Quality Compliance Specialist II

Benefits

Additional Information

The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us. Meet the Team Our Quality Assurance team are looking for a dynamic and skilled Quality Compliance Specialist II (onsite role) to support the start-up of our first European manufacturing site in Athenry. The Quality Compliance Specialist II supports the organization in ensuring compliance with applicable government regulations, industry standards, and internal policies/ procedures. Performs evaluation of internal operations, product/ process controls, communications, risk assessments and maintenance of documentation as related to quality and regulatory compliance. Consequently, they would recommend and support appropriate changes at a site or global level. Supports internal and external audits to identify, evaluate, disclose and appropriately remedy risks and deficiencies within the Dexcom QMS. Coordinates the preparation of document packages for regulatory submissions from all areas of company as well as for internal and external audits and inspections. Where you come in: You will support Quality and Compliance Activities: Oversee the quality and compliance aspects of establishing and maintaining processes related to commercial product shipment and release from Dexcom Ireland and global distribution centres. You will work on supporting and maintaining Quality Plans to ensure that Dexcom's medical devices meet regulatory, customer, and internal quality requirements throughout the product lifecycle. You will own and manage change orders impacting the Quality Management System (QMS). Facilitate cross-functional collaboration across departments and sites to ensure changes are thoroughly assessed and effectively implemented. You'll lead/ support Corrective and Preventive Action (CAPA) investigations and drive process improvement initiatives related to the QMS. Ensure timely resolution and effectiveness verification. You will provide guidance and support in assessing changes to QMS documentation, ensuring compliance with applicable standards and regulations. You will lead or support the integration of new regulations or QMS standards by conducting gap assessments, recommending updates, and driving documentation revisions. You will lead/ support ongoing improvement and maintenance of the QMS to enhance operational efficiency, compliance, and product quality. You'll conduct internal audits and support external inspections by regulatory bodies and notified parties. Ensure audit findings are addressed and closed effectively. Prepare quality system documentation and records for internal and external audits/ inspections. You will lead/ support compliance-related training initiatives within the Quality Department, ensuring that all personnel are trained to meet regulatory, GMP, and internal quality standards. This role supports audit readiness, continuous improvement, and the development of a strong quality culture. You will define, monitor, and report on key quality metrics and performance indicators (e.g., CAPA closure rates, deviation trends, audit findings) as part of Management Review and internal metric review meetings. Other Duties as Assigned: This job description reflects management's assignment of essential functions and does not restrict additional responsibilities that may be delegated. What makes you successful: You bring experience with Quality Management Systems, Audits, CAPA, Change Management, Management Review You are knowledgeable in ISO 13485:2016, CFR Part 820, ISO 14971, CMDR and other regulations applicable to Medical Devices. You will be collaborative, able to work effectively with diverse functional groups, able to multitask and adjust to change in priorities To perform this job successfully, an individual